Drug Preserves Functional Status in Alzheimer's Patients

AlzheimerSupport Staff
April 6, 2000

SUMMARY: Researchers report that the drug donepezil has been found to help postpone functional impairment in Alzheimer's patients.

ABSTRACT: A study titled, "Donepezil Preserves Functional Status in Alzheimer's Disease Patients: Results from a One-year Prospective Placebo-controlled Study," reported that donepezil, a piperidine (liquid heterocyclic – a ring shape structure made of atoms)-based acetylcholinesterase inhibitor (meaning it represses the action) of acetylcholine, a major neurotransmittor, a substance that transmits nerve impulses across the synapse (or gap) in order to stimulate a skeletal muscle may help postpone Alzheimer's disease's (AD) inevitable deterioration and slow the loss of function AD patients experience.

The study, presented at the 13th Annual Meeting of the American Association for Geriatric Psychiatry (AAGP), is unique since it takes two types of function oriented activities into consideration. Researchers tested the patients ability to perform typical activities such as bathing and dressing as well as their ability to execute instrumental activities of daily living such as shopping and food preparation. To test these activities, the researchers used a new scale created specifically for Alzheimer's disease; the Alzheimer's Disease Functional Assessment and Change Scale (ADFACS), a 16-item functional assessment scale, which is designed to eliminate gender bias. This scale is an improvement on previous scales since it includes instrumental items that reflect the functional impairment of mild to moderate Alzheimer's disease.

The study included patients who had possible or probable Alzheimer's disease. It was a multi-center study, employing once daily doses of either placebo or a 10 mg/daily dose of donepezil. Patients randomized to donepezil received 5 mg for 28 days prior to raising their dosage to 10-mg/daily. The researchers had defined criteria for clinically evident functional decline and judged participants using that criteria, explained Dr. Raymond D. Pratt, an author of the study. Patients were excluded from the study if they were determined to have experienced functional decline (using the study's criteria).

The study included 431 participants, 217 received placebo and 214 received donepezil. The study population consisted of approximately 65 percent female, which is typical for an Alzheimer's population study in the US. Nearly 20 percent of the placebo group and about 31.3 percent of the donepezil group completed the study without experiencing any of the criteria for functional decline. Findings show about 56 percent of the placebo group compared with 41 percent of the donepezil group had criteria for clinically evident functional decline and were removed from the study.

Drug treatment was found to have a significant impact on the median time of functional decline. The median time for functional decline was 208 days in the placebo group and 357 days in the donepezil group. There was no clinically evident decline in 51 percent of patients treated with donepezil after 48 weeks of treatment, compared with only 35 percent of placebo patients. The risk of clinically evident functional decline of the patients receiving donepezil was about 62 percent of the amount of the placebo group.

"This is the first US study of acetylcholinesterase inhibitors to evaluate the effects of one year's therapy in patients with Alzheimer's disease," reported Richard Mohs, PhD, professor in the department of psychiatry, Mount Sinai School of Medicine, and the study's lead investigator. In a press statement, Dr. Mohs also said that the findings of this study suggest that prolonged treatment with donepezil is an important weapon to help patients improve or maintain their independence while living with the disease.

Researchers observed that Alzheimer's disease continued to progress over time yet donepezil significantly delayed functional loss. In fact, patients taking donepezil maintain their functional ability for about five months longer (median time) than those on placebo.

Researchers reported that donepezil is generally well tolerated by patients. The most common adverse reactions experienced by the donepezil group were nausea, vomiting, anorexia, headache and urinary tract infections. They found no significant differences between the placebo and donepezil groups that were treatment related.

"This study particularly brings out the new scale, the ADFACS, that was developed specifically for this study and overcomes a number of the problems with previous ADL scales that have been used in clinical trials. Specifically, it adds new items into the ADL scale - particularly instrumental activities that eliminate gender bias and are specific for patients with mild to moderate Alzheimer's disease and are clinically evident within the population that we're studying," Dr. Pratt explained.

Source: Doctors Guide